The big picture: what counts as “new” cancer medicines from Russia?
In the last decade, Russia’s oncology ecosystem has shifted from mainly producing generics and biosimilars to launching a small but growing pipeline of original (originator) therapeutics and platforms. The headline example is prolgolimab—an anti-PD-1 immune-checkpoint inhibitor developed by the Saint-Petersburg biotech BIOCAD—which became the first Russian-origin checkpoint inhibitor to win domestic approval (initially for melanoma), and is now being pushed into combination regimens for lung cancer. Russia is also accelerating radiopharmaceuticals/theranostics (particularly PSMA-targeted agents for prostate cancer), and experimenting with personalized cancer vaccines and immunomodulatory biologics that were first engineered in the 1990s and 2000s. These efforts exist alongside continued work in supportive care, diagnostics, and nuclear-medicine infrastructure. TPU News+3EurekAlert!+3PubMed Central+3
That said, the global headlines you may have seen about a “finished, 100% effective” Russian mRNA cancer vaccine (“Enteromix”) require caution. Russian centers are indeed advancing cancer-vaccine programs, and early preclinical/early-phase signals are being touted in the press—but independent verification and late-phase clinical data are not yet available. Multiple outlets amplified the claim; fact-checking indicates these vaccines are not past early trials and are not approved for routine use. Treat any “ready for clinical use” headlines as premature until peer-reviewed data and regulatory actions are published. Snopes+3The Times of India+3The Times of India+3
With that context in place, let’s trace the arc—from history to modern tools to specific Russian programs.
A brief history: from Soviet-era oncology to homegrown immunotherapy
Soviet oncology emphasized radiotherapy, surgery, and classic cytotoxic chemotherapy, while building a strong physics-and-materials base in nuclear medicine (reactors, cyclotrons, isotopes, dosimetry). That infrastructure laid the groundwork for today’s Russian interest in theranostics (paired diagnostic/therapeutic radiopharmaceuticals). After the 1990s, research groups began exploring immunomodulators—notably TNF-based constructs—aiming to harness anti-tumor immunity with reduced systemic toxicity.
One long-running Russian program is REFNOT® (TNF-T)—a recombinant fusion of tumor necrosis factor with thymosin-α1 designed to retain antitumor activity with lower toxicity and confer immune-stimulating properties. The sponsor reports origin in the early 1990s with continuing clinical experience domestically; however, peer-reviewed, large randomized data accessible in international journals remain limited, and global regulators have not approved it. REFNOT illustrates an early Russian attempt at cytokine-engineering immunotherapy long before checkpoint inhibitors became mainstream. refnot.ru+1
Key historical takeaway: Russia’s oncology R&D lineage runs deep in immunomodulation and nuclear medicine—two domains that are highly relevant to today’s pipelines in checkpoint blockade, cancer vaccines, and PSMA-targeted theranostics.
How modern technology reshaped Russian cancer-drug development
1) Immuno-oncology & checkpoint inhibitors
The global revolution in PD-1/PD-L1 blockade catalyzed efforts in Russia to develop domestic originator antibodies. BIOCAD’s prolgolimab (BCD-100) is a fully human IgG1 anti-PD-1 with an Fc-silencing “LALA” mutation to reduce Fcγ-receptor interactions. It became the first Russian-devised PD-1 inhibitor cleared by Russia’s Ministry of Health for unresectable/metastatic melanoma. This approval drew on multi-center clinical studies (e.g., MIRACULUM) and has been followed by phase III work combining prolgolimab with platinum/pemetrexed for first-line non-squamous NSCLC; those data are now appearing in the literature and were used for domestic approvals in lung cancer settings. EurekAlert!+2PubMed Central+2
The significance here is twofold: (a) scientific—demonstrating capacity to generate a homegrown checkpoint antibody with competitive pharmacology—and (b) strategic—reducing reliance on imported I/O drugs and enabling Russian-led combo studies tailored to domestic practice.
2) Radiopharmaceuticals & theranostics
Russia’s physics pedigree and reactor access naturally lead into theranostics—paired agents for imaging (e.g., Ga-68/^18F-labeled PSMA PET) and therapy (e.g., ^177Lu-PSMA). Russian centers have reported preclinical efficacy for domestically produced ^177Lu-DOTA-PSMA and the first “made-in-Russia” theranostic PSMA pair advancing into pilot clinical studies led by Tomsk Polytechnic University (TPU). Researchers and trade media describe successful initial pilot trials and patenting of these molecules—an important step toward sovereign capability. GxP News+3PubMed+3siboncoj.ru+3
Why this matters: PSMA theranostics (pioneered abroad) have transformed care for certain prostate cancer populations. Domestic PSMA agents promise better supply security, lower costs, and the freedom to iterate formulations or trial designs in-country.
3) Personalized cancer vaccines & oncolytic platforms
Russian national cancer centers (e.g., N.N. Blokhin National Medical Research Center of Oncology) have been assembling pipelines for oncolytic and personalized vaccines, preparing phase I clinical recruitment in 2024–2025, after completing preclinical packages reporting tumor growth delay and, in some models, complete responses. These efforts align with global trends in neoantigen-targeted mRNA/DNA vaccines and viral immunotherapy. Still, as of now, these are early clinical programs, not approved therapies. ФГБУ «НМИЦ радиологии» Минздрава России
In contrast, highly publicized claims around “Enteromix,” an mRNA cancer vaccine allegedly showing “100% efficacy,” are not yet supported by peer-reviewed clinical data or regulatory approvals, according to independent fact-checking. This area remains promising but unproven until rigorous trials read out. Snopes
4) Adjacent Russian research: mitochondria-targeted drugs
Russian labs (e.g., the Skulachev group) have explored mitochondria-targeted antioxidants like SkQ1. While primarily investigated for aging/ophthalmology, there is preclinical evidence of tumor growth suppression under certain conditions. These studies are exploratory—not approved cancer medicines—but illustrate the breadth of mechanistic ideas in Russian biomedicine. PubMed Central+1
Case study: prolgolimab (BIOCAD) as Russia’s flagship originator I/O drug
Mechanism and engineering. Prolgolimab binds PD-1, releasing the immune “brakes” on T cells. The IgG1 LALA Fc mutation reduces Fcγ-receptor effector functions (e.g., ADCC), a design aligned with modern PD-1 antibodies to avoid off-target depletion of PD-1-bearing T cells. BIOCAD
Development path.
- Melanoma: Russian approval followed phase II evidence of activity and tolerability in advanced melanoma. A 2024 phase-III publication further characterizes its role; BIOCAD has framed prolgolimab as the first Russian PD-1 approved for first-line melanoma. PubMed Central+1
- Lung cancer: The DOMAJOR phase III trial tested prolgolimab + platinum/pemetrexed vs. placebo + chemo in first-line non-squamous NSCLC; results and corresponding publications show the strategy is clinically credible enough to underpin domestic approvals in this setting, expanding indications beyond melanoma. PubMed
Why it matters. An originator checkpoint drug marks a technological inflection point—demonstrating Russian capability to discover, engineer, and advance complex biologics; enabling homegrown combos (e.g., with Russian chemo backbones); and providing a platform for future bispecifics, Fc-engineered variants, and vaccine-checkpoint combinations.
Radiotheranostics made in Russia: the PSMA push
PSMA (prostate-specific membrane antigen) is an excellent theranostic target: ^68Ga/^18F tracers for PET imaging precisely map disease, while ^177Lu-PSMA can deliver targeted radiation to tumor sites. Russian oncologists and nuclear-medicine centers are building domestic capacity across the chain—ligand chemistry, radiolabeling, dosimetry, preclinical validation, and clinical pilots. Russian authors have published reviews and clinical experience with PSMA PET/CT and ^177Lu-PSMA therapy, and Tomsk researchers report first-in-Russia PSMA theranostic molecules with pilot clinical success. siboncoj.ru+2PubMed+2
Why it matters. Theranostics integrate precision imaging with precision therapy, often improving outcomes for metastatic castration-resistant prostate cancer in international studies. Domestic innovation could mean more consistent access for Russian patients and faster iteration for next-gen ligands (e.g., alpha-emitters) inside Russia.
Russian cancer vaccines: separating signal from noise
What’s real right now
- Multiple Russian institutes are moving oncolytic and personalized cancer vaccines into first-in-human testing starting late 2024/early 2025, after reporting effective preclinical antitumor responses. Patient recruitment has been announced by national cancer centers. This is consistent with global efforts exploring neoantigen mRNA vaccines and viral immunotherapies for melanoma and other solid tumors. ФГБУ «НМИЦ радиологии» Минздрава России
What’s still unproven
- Media reports about “Enteromix” suggest high efficacy and pending free-to-patients availability. However, independent analysis finds the claims overstated relative to the available evidence, with no peer-reviewed human clinical outcomes published to support definitive efficacy. Until we see phase II/III data and a regulatory label, “cancer vaccine ready for clinical use” remains aspirational. Snopes
Bottom line: Russian cancer-vaccine work is advancing and plausible given global momentum—but it’s not yet a finished, approved medicine.
Other Russian-origin efforts worth knowing
- TNF-T (REFNOT®): An engineered TNF + thymosin-α1 fusion designed to maintain antitumor effects at reduced systemic toxicity and boost immune activity. It represents early Russian innovation in cytokine fusion biology, with domestic clinical use claims; however, global late-phase data and registrations are lacking. refnot.ru+1
- Mitochondria-targeted antioxidants (SkQ1): Russian groups reported preclinical tumor-growth suppression and mitotic effects in certain models. This is interesting translational science—not an approved cancer therapy. PubMed Central+1
(Note: Some oncolytic-virus brands you may see online (e.g., Rigvir) are non-Russian in origin and have faced regulatory reversals abroad; they should not be conflated with current Russian programs.) PubMed Central+2PubMed Central+2
How Russia builds these medicines: enablers and constraints
Enablers
- Integrated biopharma like BIOCAD: End-to-end capabilities (antibody discovery, cell lines, CMC, clinical ops) are critical to advance originator biologics such as prolgolimab. BIOCAD
- Nuclear-medicine infrastructure: Reactor/cyclotron access and historical strengths in physics/engineering support isotope production and radioligand development for theranostics (e.g., PSMA). siboncoj.ru
- National programs: Initiatives like Priority-2030 have funded university-based translational work (e.g., TPU’s PSMA theranostics pilot). TPU News
Constraints
- Global integration & validation: Sanctions and reduced collaboration can limit multinational trials, external peer review, and regulatory convergence—all essential to prove generalizability beyond Russia.
- Evidence standards: To shift from promising lab/phase-I signals to standard-of-care status, Russian programs need large, randomized, peer-reviewed datasets and transparent safety reporting comparable to EMA/FDA norms.
Current status (as of September 19, 2025, Asia/Colombo time)
- Approved, Russian-origin I/O: Prolgolimab—approved domestically for melanoma; combination chemotherapy regimens for NSCLC have phase III support and domestic approvals referenced in the literature and sponsor communications. EurekAlert!+2PubMed Central+2
- Radiotheranostics: First domestic PSMA theranostic pair reported by TPU has completed pilot clinical trials and is moving forward; broader clinical deployment depends on further trials and regulatory milestones. TPU News+1
- Cancer vaccines: Early-phase clinical recruitment announced; no Russian vaccine has completed late-phase trials or obtained routine-use approval. Widely circulated “Enteromix” claims remain unverified by peer-reviewed clinical data; treat them as preliminary. ФГБУ «НМИЦ радиологии» Минздрава России+1
- Legacy immunomodulators: Agents such as REFNOT® continue to be promoted domestically; international late-phase evidence remains limited. refnot.ru
What to watch next
- Head-to-head and combo data for prolgolimab.
Comparative evidence versus global PD-1/PD-L1 standards, biomarker-stratified analyses, and real-world safety/immune-toxicity profiles will determine how Russian oncologists position prolgolimab within I/O algorithms. PubMed - PSMA theranostic scaling.
Movement from pilot to multi-center Russian trials, dosimetry optimization, and potential alpha-emitter derivatives would indicate a maturing domestic platform. TPU News - Cancer-vaccine readouts.
Watch for phase I/II publications from N.N. Blokhin and partner institutes. Positive safety/immunogenicity with clear, radiographically confirmed responses—ideally in a well-controlled setting—would move the narrative from hype to evidence. ФГБУ «НМИЦ радиологии» Минздрава России - Regulatory transparency.
Broader adoption will hinge on public trial registries, peer-reviewed publications, and clear labels from the Russian Ministry of Health, ideally with bridging studies that meet ICH-style standards. ClinicalTrials.gov
Practical implications for patients and clinicians (inside and outside Russia)
- Inside Russia: The availability of prolgolimab offers a domestic I/O option, potentially improving supply and cost dynamics. If PSMA theranostics reach wider deployment, patients with advanced prostate cancer could see improved access to precision radioligand therapy. Cancer-vaccine trials may offer clinical-trial slots for select indications. PubMed Central+2PubMed+2
- Outside Russia: Until there are international trials or reciprocal regulatory pathways, access to Russian-origin drugs will remain limited. Nevertheless, Russia’s work—especially in theranostics and originator I/O—adds to the global innovation pool and could generate collaborations once robust data appear.
Conclusions
- Real advances: Russia has genuinely fielded an originator checkpoint inhibitor (prolgolimab) with melanoma approval and expanding lung-cancer evidence, and it is building a domestic PSMA theranostics capability that has cleared pilot clinical milestones. TPU News+3EurekAlert!+3PubMed Central+3
- Promising but early: Personalized cancer vaccines (including widely publicized mRNA efforts) are in early clinical phases; claims of “ready for use” or “100% efficacy” are not yet substantiated by peer-reviewed clinical outcomes or approvals. Snopes
- Heritage matters: Decades of Russian work in immunomodulation (e.g., TNF-based constructs like REFNOT®) and nuclear medicine underpin today’s push in I/O and theranostics. refnot.ru
- Next steps: Expect more combination trials, dosimetry-optimized theranostics, and first-in-human vaccine readouts. The crucial test will be transparent, peer-reviewed, late-phase evidence that convinces both domestic and international oncologists.